News announced during the 37th J.P. Morgan Healthcare Conference (#JPM19): Dublin medtech HealthBeacon raises $12m in a Series A round

Reporter: Gail S. Thornton

HealthBeacon’s Smart Sharps system helps patients adhere to their medication schedule. The company was founded by Jim Joyce and Kieran Daly in 2013, and opened offices in Boston in 2017. The digital platform, which last year received vital FDA clearance for the US market, not only ensures that patients keep up with their injectable treatments, but also allows them to dispose of medication in a safe way, and keeps carers up to date with the patients’ progress.

Published January 8, 2019 by John Kennedy, Silicon Republic.

From left: Co-founders Kieran Daly and Jim Joyce. Image: HealthBeacon

With funding and FDA approval under its belt, this Dublin tech start-up has plans to help patients stick to their medication schedule.

Dublin and Boston digital health company HealthBeacon has raised $12m in a Series A investment round that brings total investment in the company to almost $15m.

The round was organised by HealthBeacon and Cantor Fitzgerald, led by Oyster Capital and Elkstone Partners, and the investment syndicate included Quorndon Capital and Cantor Fitzgerald’s private client group. Earlier investors in HealthBeacon include Enterprise Ireland, BVP and a range of angel investors.

‘I know with confidence as to whether my patients are adhering to their treatment strategy’– DOUG VEALE

“Cantor has a major focus on life sciences and on digital health, and we have every confidence that CEO and co-founder Jim Joyce has created a true sector leader in HealthBeacon,” said Liam Kiely, director of Cantor Fitzgerald.

The announcement was made in San Francisco at the JPMorgan Chase Biotech Showcase. The funding comes on the back of rapid global expansion of the FDA-cleared HealthBeacon Smart Sharps technology.

The right stuff

Dublin-based HealthBeacon’s Smart Sharps system helps patients adhere to their medication schedule. The company was founded by Jim Joyce and Kieran Daly in 2013, and opened offices in Boston in 2017.

The digital platform, which last year received vital FDA clearance for the US market, not only ensures that patients keep up with their injectable treatments, but also allows them to dispose of medication in a safe way, and keeps carers up to date with the patients’ progress.

The funding from this Series A will be used to launch its Smart Sharps system in the US and to develop its portfolio of medical adherence tools for high-value medications.

In 2017, HealthBeacon revealed plans to create 20 new jobs in Dublinin roles spanning IT, software development, project management and customer service. As of today, HealthBeacon operates in 10 markets and has tracked more than 200,000 home-based injections, making it one of the largest global deployments of a medical adherence device. Today, HealthBeacon employs more than 30 people and plans to double the team over the next 18 months.

The addressable market for injectable medications has reached nearly $50bn, according to the company. The Smart Sharps bin system by HealthBeacon has made it easier for patients using injectable medications to stay on track with their treatment. This has resulted in improved patient medication adherence, driving patient care.

In December, HealthBeacon was named eHealth Innovation of the Year by the Irish Medtech Association.

“I’ve been using the HealthBeacon for over two years, and their Smart Sharps bin has had a profound impact on how patients manage their treatment,” said Doug Veale, professor of rheumatology at St Vincent’s Hospital in Dublin.

“I know with confidence as to whether my patients are adhering to their treatment strategy.”

Bad News this Week for Biotech Deals?

Curator: Stephen J. Williams, Ph.D

Last week in biotech ( 3/7-3/11/2016) had a plethora of disappointing stories related to biotech drug development and hits to biotech investing and VC. Since October of 2016 the biotech index has lost 35% to today (see Biotech ETFs Hit 52-Week Lows: Time to Buy?) however were the hit back in October a signal of some of the listed events below (as shown on Biospace News) and includes:

an long-time biotech startup with failure of mesothelioma trial who has struggled in the past

multiple clinical trial failures forces the de-listing of a NASDAQ company (other biotechs this year had similar problems)

more problems with drug development for Duchenne’s Muscular Dystrophy

GlaxoSmithKline dumps Five Prime’s cancer drug in the midst of Phase I

GSK gave Five Prime a 180-day notice that it’s nixing its license to the company’s FP-1039, which is designed to block the spread of cancer by interrupting protein signaling. The decision follows GSK’s January move to stop developing FP-1039 in squamous non-small cell lung cancer due to the rise of immuno-oncology therapies from Merck ($MRK), Bristol-Myers Squibb ($BMY) and others, citing a “change in treatment paradigms.”GlaxoSmithKline ($GSK) is cutting ties with Five Prime Therapeutics’ ($FPRX) in-development cancer therapy, backing out in the middle of a mesothelioma trial.

Now GSK is set to abandon a drug it inherited through its $3 billion acquisition of Human Genome Sciences in 2012, leaving Five Prime to go it alone in an ongoing Phase Ib study testing FP-1039 against mesothelioma. Five Prime said it plans to work with GSK to complete enrollment in the study, adding that it “continues to be encouraged” by the drug’s potential in mesothelioma.

3/11/2016 6:39:17 AM

BERKELY, Calif. – Troubled XOMA Corp. (XOMA) is terminating half of its workforce after a late-stage failure of its experimental drug gevokizumab for treatment of pyoderma gangrenosum, the San Francisco Business Times reported this morning.

Following the announcement, Xoma’s stock is down this morning about 5 percent, trading at 91 cents per share as of this writing.

Xoma said it is interested in divesting itself of gevokizumab. In a statement, the company said several companies have approached Xoma about acquiring the drug. Gevokizumab binds to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine. Xoma said it will make all information about the drug and study information available to potential buyers. Gevokizumab has had a troubled history with Xoma. The company has halted several trials with the drug for various diseases, including diabetes and a blinding eye disease, the Times reported. In 2014, Xoma was forced to stop testing gevokizumab as an arthritis treatment after the drug did not show significant benefit against placebo after a six-month period.

3/10/2016 6:07:38 AM

With one piece of bad news after another, Cambridge, Mass.-based Eleven Biotherapeutics Inc. (EBIO) filed a Form 8-Kwith the U.S. Securities and Exchange Commission, addressed a delisting notification it received from the Nasdaq on Mar. 3.

The Nasdaq informed the company that its stock dropped below $1 a share, and that the stockholder equity didn’t comply with the $5,000,000 minimum stockholders’ equity requirement. As a result, it has 180 days to comply with Nasdaq rules.

On Jan. 10, the company announced that its Phase III clinical trial of EBI-005 (isunakinra) for severe allergic conjunctivitis did not meet its primary endpoint.

In May 2015, the company reported that its drug, EBI-005, for moderate to severe dry eye disease, failed to prevent damage to the cornea or reduce eye pain in comparison to the control group.

In a January statement, Abbie Celniker, president and chief executive officer of Eleven Biotherapeutics, said, “We are disappointed that isunakinra failed to meet its primary endpoint, and based on these overall results we see no immediate path forward in allergic conjunctivitis. Our efforts will be focused on submitting an investigational new drug application (IND) for EBI-031 in diabetic macular edema in the first half of 2016.”

EBI-031 was designed for intravitreal delivery using the company’s AMP-Rx platform. The drug blocks both free IL-6 and IL-6 complexed to the soluble IL-6 receptor (IL-6R). The compound is being developed to treat diabetic macular edema (DME) and uveitis.

Cambridge, Mass.-based Sarepta Therapeutics (SRPT) announced yesterday that it was shuttering its research-and-development manufacturing facility in Corvalis, Ore. Most of the employees there are expected to move to Sarepta’s facilities in Andover and Cambridge, Mass. About 30 people are expected to be laid off.

On Jan. 21, Sarepta announced that, with an impending snowstorm on the east coast, the U.S. Food and Drug Administration (FDA)’s meeting to review the company’s New Drug Application (NDA) for eteplirsen to treat Duchenne Muscular Dystrophy (DMD) was postponed.

DMD is a muscle wasting disease caused by mutations in the dystrophin gene. The disease is progressive and generally causes death in early adulthood. Complications include serious heart or respiratory-related problems. It mostly affects boys, about 1 in every 3,500 to 5,000 male children.

On Jan. 15, an FDA advisory committee decided to reschedule the meeting, at which point a recommendation or approval decision will be made. That meeting of the Peripheral and Central Nervous System Advisory Committee has not been rescheduled yet, but Sarepta believes it will be prior to May 26, which is the PDUFA date. The Prescription Drug User Fee Act (PDUFA) is a law that allows the FDA to collect an application fee from drug companies when an NDA or Biologics License Application (BLA) is submitted.

The DMD drug arena has been fraught with failures and bad news this year. San Rafael, Calif.-based BioMarin Pharmaceutical Inc. (BMRN)’s application for its DMD drug Kyndrisa (drisapersen) was turned down by the FDA on Jan. 15. The FDA argued that Kyndrisa didn’t show enough benefit.

On Jan. 25, Cambridge, Mass.-based Akashi Therapeuticsannounced that it had halted its DMD trial for HT-100 after one of its patients developed serious, life-threatening health problems. In that DMD is a serious, life-threatening health problem in itself, it’s not clear if the patient’s problems are directly related to the drug. The patient was receiving the highest dose in the HALO trial, while others in the trial with lower doses were not showing adverse side effects.

I wanted to highlight an interesting interview (What it Really Takes to Get Money for Your Startup) with David S. Rose, serial entrepreneur and Founder and CEO of Gust.com, which is a global collaboration platform for early stage angel investing, connecting hundreds of thousands of entrepreneurs and investors in over 75 countries. The interview with David and CFA John P. Gavin was broadcast on the podcast Quiet Innovation (from PodCast Addict @Podcast_Addict) from. I had tweeted it out on my Twitter account below (see the http link)

… but will include some notes from the podcast here. In addition you can link to the podcast directly using the links below:

David Rose discusses how there are hundreds of thousands of new ideas, some which are great some which are not… having an idea may be an initial step but for an investor to even consider your idea it is more important to have

EXECUTION

This is what David feels is critical to investors, such as himself, to decide whether your idea is investable. A startup needs to show they can accomplish their goal and show at least a rudimentary example of this, whether it is putting up a website or writing up a design blueprint for a new widget. He says starting a business today (either tech or manufacturing) requires a lot less capital than years ago (unless you are starting a biotech). He gives an example of internet startups he had founded in the 90’s versus today… in the 90’s you needed $2 million… today you can do it for $2,000. But the ability to show that you can EXECUTE this plan is CRITICAL.

David sites three aspects which are important to investors:

Integrity – Be humble about yourself. He says there are way too many people who claim ‘our idea is the best’ or ‘we do it better than anyone’ or ‘we are the first to have this idea’. As he says Jeff Bezos of Amazon was not the first to have the idea of selling books over the internet, he just EXECUTED the plan extremely well.

Passion- Investors need to see that you are ‘all in’ and committed. A specific example is angels asking how much money have you put into your idea (skin in the game)

Experience- David says there are TWO important types of experience in developing startups and both valid. The first is how many startups have you done and succeeded and the second is how many startups have failed. He says investors actually like if you have failed because they are learning experiences, just as valuable if not more than having startups always succeed. Investors need to know how you can deal with adversity. All three points goes back to execution.

Eris Reese’s post The Lean Startup in his blog StartUpLessonsLearned – being frugal (gets back to what he said about not needed as much capital as you would think i.e. Don’t Burn Through the Cash) and also get metrics on your startup or idea (as long as you have the IP). He suggests taking out an ad to see what the interest is out there. You can measure the clicks from the ad and use that as a marketing tool to potential investors i.e. Getting Feedback

“

“Eavesdropping on investors‘ closed door discussions” gives entrepreneurs the inside track on what happens after a start-up company presents to investors. Typically, after a start up company’s team leaves the room investors have a private discussion about whether the opportunity merits further investigation and possible investment. 1st Pitch Life Science-Philadelphia offers local company presenters and audience participants the chance to listen in on these closed door discussions to learn what really matters to investors. This event offers excellent networking opportunities for investors, university technology transfer professionals, entrepreneurs, and business professionals in the Philadelphia entrepreneurial ecosystem. It provides a supportive learning environment for entrepreneurs.

“

For more information about Mid-Atlantic BioAngels and to make a submission for evaluation of your startup please visit their

Mid-Atlantic Bioangels was formed in 2013 to provide an unmet need in the Mid-Atlantic region for early-stage life-science entrepreneurship, providing early life science entrepreneurs a venue to present their companies, obtain funding and provide mentoring, feedback, networking, and information for corporate development. A great article by Kira M. Newman can be found here

Meeting Coverage

Three companies are to be presented

Hastke Inc is a device company with a best-in-class, real-time 3D visualization technology that can de-risk the drug development process for pharma. In the future, their technology has the potential to become an important diagnostic tool for physicians.

LytPhage is a new biotech company using novel bioengineering to develop therapeutics to address the worldwide crisis of antibiotic resistant organisms. They are developing a treatment for vancomycin resistant systemic infections with their platform, which can be adapted for other problematic organisms.

RAbD Biotech uses proprietary computational methods to design biologic agents capable of treating severe diseases. RAbD’s lead product candidate is a potential first-in-class treatment for ovarian cancer, a disease characterized by late detection, few therapeutic options, and high mortality.

The meeting format includes:

15-20 minute meeting presentation

group discussion/questions

panel opinions (panel of experienced venture capitalists)

Notes from the meeting will be put in future postings.

Please also see Twitter handles for meeting coverage using the following hashtags and handles

Every scientist usually can describe an event or an admired historical figure as their pivotal point of inspiration which led them to embark on a scientific career.

I will admit there were two points of inspiration: the first was Jacques Cousteau while watching his program Undersea World of Jacques Cousteau.

The other (and please don’t laugh) was reading about the intellectual duel and collaboration between two of the greats in astronomy and mathematics: Tycho Brahe and Johannes Kepler, two historical figures responsible for our modern-day understanding of the universe and planetary motion. For some reason I had romanticized the study of science, envisioning days in the laboratory wearing renaissance garb while striking medieval vogue poses (just kidding). But back then, accurately determining planetary motions and mapping the stars was a real big deal, as trade ships would rely on the positioning of stars as their heavenly GPS system. Otherwise you might be trying to establish a new trade route to India and wind up somewhere… say America.

Tycho Brahe (1546-1601; born Tyge Ottesen Brahe) was a Danish nobleman and scientist who made the most accurate measurement of planetary motion and positioning of the stars, which enabled another great astronomer, Johannes Kepler, to deduce the laws of planetary orbits. His measurements allowed Kepler to prove Copernicus’s sun centered theory (Earth revolves around the sun). An interesting history of Brahe, The crazy life and crazier death of Tycho Brahe, history’s strangest astronomer, gives some in-depth look at this intriguing historical figure.

Now back then science, as is the case now, costs money; and the two ways to get that money was either find a wealthy backer (like a king) or have a rich uncle who leaves a great inheritance. Well Tycho did have a rich uncle who left him a lot of money, but instead of just sitting around spending it on jewelry, he used a great portion of his inheritance to build his 1st observatory to make his important measurements and also discover a supernova (published in De Nova Stella), breaking the dogma at the time that stars never changed their appearance or position.

(Photo Credit: Wikipedia)

There have been other examples of self-funded scientists including:

i. Luther Burbank (b:1845) who led the way for plant genetics. After developing the Burbank potato he used the money from his nursery business to buy a farm to conduct plant breeding experiments

ii. Dr. Edward Jenner who used his own funds to develop the first smallpox vaccine and later awarded money from Parliament for his development

iii. Ritu Levi Montalcini, M.D.: Dr. Montalcini discovered nerve growth factor together with Stanley Cohen (both awarded Nobel Prize). After earning an MD in Turin, Italy in 1938 she was unable to work as Mussolini banned Jews from holding professional positions. So she moved to Belgium but when the Nazi’s took over she fled back to Turin and made a secret lab to study the development of neurons in chick embryos.

Now as many government science budgets are tightening some scientist are returning to self-funding and alternative models in order to continue their research.

The Ronin Institute

One such example is the Ronin Institute, founded by Dr. Jon Wilkins, Ph.D., where scientists who may not have institutional support, band together in a sort of virtual Institute which supports publication and grantsmanship. The mission and values of the Ronin Institute (which can be found here) includes creating new models for the conducting, funding, collaboration, and dissemination of scholarly research to get researchers back to what they do best: RESEARCH.

The following is an excerpt from the article about independent researchers:

“

One of us (Jon Wilkins), has set out to promote and support independent scholarly research through the founding of the Ronin Institute. The Ronin Institute acts as an aggregator for the fractional scholars of the world, providing an institutional affiliation, connection with other fractional scholars, and support for conference travel and grant applications.

When people are doing something that they are passionate about, they work harder and produce a better product. Thus, underemployed scholars represent in some sense a good that is currently trading well below its actual value. By providing a mechanism for those who wish to conduct research, we can allow these people to engage in their passions while growing the base of scholarly knowledge, which in turn has the potential to create further economic growth.

Through the Ronin Institute, we will be harnessing the skills and talents of thousands of underemployed researchers.

Two other great articles on “gentlemen scientists” or self-funding scientists can be found at the Singular Scientist blog post entitled “Self-Funding in Science” and a 1998 Science article by Jon Cohen entitled Scientists Who Fund Themselves. In each case, scientists felt freed up from the financial overhead accompanied with big institutions and realized more time for their research.

Alternate Funding Source: CROWDSOURCING

The passage of the JOBS act has relieved some of the pressures off obtaining funding for companies through crowdfunding mechanisms. Scientists are also turning to crowdsourcing mechanisms to fund their research. An article in the Washington Times (Scientists discover ‘crowdfunding’ as a way of replacing research grants) highlights some of the successes and science-related crowdfunding sites that exist.

Digital Tools and Lab Space for the Self-Funding Scientist

Dr. Elizabeth Iorns, breast cancer researcher and founder and CEO of Science Exchange, an online marketplace for ordering science experiments from various nationwide and worldwide labs, explains in a three-part Nature blog post “Research 2.0.1: The future of research funding” how the traditional government-based grant-funding model may transition into a more crowdfunding model. For example Science Exchange allows you to order common laboratory procedures (for example immunohistochemistry or bioinformatics analysis or gene sequencing) from a list of participating labs in the marketplace. Prices are usually reasonably priced.

Finding Lab Space: Biohacker Labs

The last piece of the puzzle is finding rented space and equipment to do research. A new type of laboratory space, small, nimble, and priced and equipped to fit the independent researcher is cropping up. Termed biohacker labs or hackubators, these small rented communal spaces are different from the traditional bio-incubators or science centers which sprang up decades ago to foster the biotech revolution. This phenomenon is explained quite nicely in a Science article by Virginia Gewen “Biotechnology: Independent Streak”. These spaces can go for $100-400 a month, much less than $900 a month for incubator space. Most of the investigators highlighted in the article get funds through crowdsourcing.

One such hackubator lab is Bio, Tech and Beyond, a DIY lab in San Diego which supports numerous projects using 3D printing, cell culture, and sequencing. These type of DIY biolabs are springing up all over, based on the idea from tech hacker DIY labs, although before the expense seemed to be the limiting factor. Now it appears the internet is once again revolutionizing another industry, namely that of the independent bio researcher

…. Sans the 16th century fashion (what a shame!)

Other posts on this site about Science Funding, Crowdsourcing, and Open Innovation include:

Healthcare by its very nature is complex. It comprises of not just one single integrated system, but consists of a large number of interrelated systems.[1] Risk[2] is inherent in the system. As a result of its complexity, it is also prone to errors due to concatenation of multiple small failures.[3] Given the fore-goings, it is unsurprising that a patient care pathway can be complex as regards the nature of care delivered and in the number of organisations that contribute to the care.[4] In parallel to this is the mounting cost of healthcare, emergence of post approval hurdle-pricing reimbursement and health technology assessments-that are more stringent.

Risk in general lacks precision both in definition and the impact it presents. There appears to be an inverse relationship between the tolerance of risk in a given society and its level of affluence. However, most affluent society seeks change in the delivery of service. This is to make for faster, efficient and effective delivery of quality services taking advantage of new technologies. The paradox is that change is front-loaded with uncertainty and it is inherently risky. In the National Health Service-as in many public organisations in developed societies that are involved in healthcare-change is influenced by the public choice theory[5] and market theory principles.[6] The government is increasingly relying on effective partnership to deliver on broad outcome measures[7] which is the nature of Public Service Agreement (PSA). Of note, it recognises that good risk management is integral to delivery of successful partnership.[8] Collaboration, co-invention and partnership have now become the buzz words in the pharmaceutical industries as part of to optimise on their research and development efforts, reduce redundant capacity and adoption of Darwinian approach to portfolio management.

The development of risk assessment and management is largely due to trends in the wider society, technological advances in health care, and the paradigm shift from paternalism to autonomy, consumerism, and clinical negligence litigation.[9] Further, in post-Vioxx world, the regulatory environment in the industry has become more challenging resulting in robust risk management and label restrictions. The political and economic trends and impacts on risk assessment and management are now more ubiquitous; and conflate and complicate the perception of risks.

Given this background, wholesale or partial significant changes in healthcare or a significant change in direction must be done circumspectly whilst factoring in inter alia: the complexity of the sector, risk management and resource reallocation among the various competing influences. According to Le Chatelier’s principle[10] which can be roughly stated as:

“Any change in status quo within a closed system will result in an opposing reaction in the responding system”.

At this stage in this discourse, it may be pertinent to look at the practical applications of change particularly with respect to research in healthcare as recently advocated by some healthcare leaders.

In December 2012, Lucien Engelen, director Raboud REshape and Innovation Centre at Raboud University Njimegen Medical Centre communicated his ‘Big Ideas 2013:The ideas include a launch of an initiative where patients together with their family and informal carers will come up with research-ideas and patients will also try to raise the money for chosen research ideas’. According to Mr Engelen, ‘This will start a new movement”.

Mr Engelen’s qualities as a visionary leader (his innovation centre is the second largest Academic Medical Centre in the Netherlands) and indeed enthusiasm are never in doubt. Neither is his honest intention to make healthcare truly participatory with patient at the very heart of service delivery. In principle participatory healthcare is laudable, given that patients come into such partnership/relationship better informed and able to negotiate better and take active part in management of their health.

However, it may be of some concern when ‘Big Ideas’ are bandied around with a complete disconnect between fundamental research and applied research. His idea of research needless to say is informed by the wisdom of the crowd and successes in other fields-art and culture, new technology etc. Healthcare is unique in more ways than one and attempts to extrapolate from other unrelated sector may have the unintended consequences that have far reaching implications.

Bold initiatives and innovation are laudable in all human efforts and endeavours, be it healthcare, other sectors, etc. The problem with the big ideas in research as advanced by Mr Englene is that it is emotive-and I dare say-has a whiff of personal imprimatur in his attempt to vivify research. Further, big ideas by its very nature, generally have at stake self beliefs, ego and personal ambitions, etc; “outcomes”[11] (as it is said torture data long enough it will confess to anything) become everything. The new game will be the end justifies the means and as a result ‘Lance Armstronging’[12]investigative studies will not be off the radar of the “researchers,” given that the vocal minority backing the effort will be banking on immediate positive outcomes. This cannot by any stretch of definition be called a scientific quest for truth. Call it by any other name-by all means-but not research. Research in healthcare is complex and is beset with vicissitudes of life. Serendipity is integral to any serious research effort and certainly it has changed lives. Part of the reasons why pharmaceutical industries have not had as many successes as previously-apart from the fact that previous research efforts have picked the low hanging fruits-is the ‘sanitised’ funding that leaves little room for serendipity. I am pleased to note that The Dean of the University where Mr Englene is based, Paul Smits, although he likes the idea-‘it brings science into the living room’-however cautioned that care ought to be exercised that the big ideas are not pursued at the expense of fundamental research.

We have to accept that certain endeavours are more difficult than others, no matter how much other disciplines may attempt to borrow from science or even language up what they do to imbricate scientific investigations. The output will be at best a pseudoscientific pretender. Einstein’s wise words are instructive: “Everything should be made as simple as possible, but not simpler”.

[9] Department of Health Making Amends: A Consultation Paper Setting out proposals for Reforming the Approach to Clinical Negligence in the NHS (2003); the cost of compensating patients jumped 400 per cent in the course of the 1970s and 750 per cent in the 1990s.

[10] This principle is native to chemistry and in its original form states that in a closed system-a chemical system-if it experiences a change in concentration, temperature, volume or pressure, the new equilibrium is achieved to counteract the imposed change.